JPWO2016039418A1 - マイクロニードルデバイス - Google Patents
マイクロニードルデバイス Download PDFInfo
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- JPWO2016039418A1 JPWO2016039418A1 JP2016547501A JP2016547501A JPWO2016039418A1 JP WO2016039418 A1 JPWO2016039418 A1 JP WO2016039418A1 JP 2016547501 A JP2016547501 A JP 2016547501A JP 2016547501 A JP2016547501 A JP 2016547501A JP WO2016039418 A1 JPWO2016039418 A1 JP WO2016039418A1
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- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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Abstract
Description
表1の記載にしたがって調製した参考例1〜4のコーティング組成物を、マスク版を用いた浸漬法により、マイクロニードル20枚にそれぞれ塗布した。なお、生理活性物質としては、参考例1、3についてはデキストラン40、参考例2についてはγグロブリン、参考例4についてはウシ血清アルブミン(BSA)をそれぞれ使用し、各参考例にはHPLCで測定するために安息香酸をトレーサーとして含有させた。また、表1中の数字は、コーティング組成物全体に対する質量%を意味する。
次に、マイクロニードルに塗布されたコーティング組成物をそれぞれ回収し、各コーティング組成物における安息香酸の含有量を測定し、生理活性物質の含有量を算出した。得られた生理活性物質の含有量の平均値、標準偏差SD、変動係数CVを算出した。なお、変動係数CVとは、標準偏差を平均値で除した値である。
表3の記載にしたがって、BSA、L−アルギニン、クエン酸、グリセリン、水を混合し、実施例1〜9及び比較例1のコーティング組成物を調製した。なお、生理活性物質として、BSAを使用した。表3中の数字は、「質量%」を意味する。得られたコーティング組成物を、マスク版を用いた浸漬法により、マイクロニードルの先端部に塗布した。次に、減圧乾燥することで、塗布されたコーティング組成物を乾燥させ、コーティング層を形成させた。コーティング層中のグリセリン含有量をガスクロマトグラフ(GC)法により、定量した。さらに、デジタルマイクロスコープ(キーエンス社)を使用して、コーティング層の性状(ひび割れの状態)を観察し、以下の評価基準にしたがい、評価した。
<評価基準>
○:ひび割れなし
△:表面にひび割れがある
×:表面にひび割れがあり、一部脱落している
表5の記載にしたがって、生理活性物質、L−アルギニン、クエン酸、含水グリセリンを混合し、実施例10〜13及び比較例2〜5のコーティング組成物を調製した。なお、生理活性物質として、それぞれヒト血清アルブミン(HSA)、リキシセナチド、黄体ホルモン放出ホルモン(LHRH)又はγグロブリンを使用した。また、含水グリセリンは、水とグリセリンの重量比が20:80のものを使用した。表5中の数字は、「質量%」を意味する。得られたコーティング組成物を、マスク版を用いた浸漬法により、マイクロニードルの先端部に塗布した。次に、減圧乾燥することで、塗布されたコーティング組成物を乾燥させ、コーティング層を形成させた。コーティング層中のグリセリン含有量をガスクロマトグラフ(GC)法により、定量した。さらに、デジタルマイクロスコープ(キーエンス社)を使用して、コーティング層の性状(ひび割れの状態)を観察し、上記評価基準にしたがい、評価した。
表8の記載にしたがって調製した実施例21のコーティング組成物を、マスク版を用いた浸漬法により、マイクロニードル20枚にそれぞれ塗布した。なお、生理活性物質としては、ウシ血清アルブミン(BSA)を使用し、蛍光プレートリーダーで測定するためにフルオレセインナトリウムをトレーサーとして含有させた。また、表8中の数字は、コーティング組成物全体に対する質量%を意味する。
次に、マイクロニードルに塗布されたコーティング組成物をそれぞれ回収し、各コーティング組成物におけるフルオレセインナトリウムの含有量を測定し、生理活性物質の含有量を算出した。得られた生理活性物質の含有量の平均値、標準偏差SD、変動係数CVを算出した。なお、変動係数CVとは、標準偏差を平均値で除した値である。
表10及び11の記載にしたがって、生理活性物質、L−アルギニン、酸、含水グリセリンを混合し、実施例25〜32のコーティング組成物を調製した。なお、生理活性物質として、それぞれヒト血清アルブミン(HSA)、リキシセナチド、黄体ホルモン放出ホルモン(LHRH)又はγグロブリンを使用し、酸として、リン酸または酒石酸を使用した。また、含水グリセリンは、水とグリセリンの重量比が20:80のものを使用した。表10及び11中の数字は、「質量%」を意味する。得られたコーティング組成物を、マスク版を用いた浸漬法により、マイクロニードルの先端部に塗布した。次に、減圧乾燥することで、塗布されたコーティング組成物を乾燥させ、コーティング層を形成させた。コーティング層中のグリセリン含有量をガスクロマトグラフ(GC)法により、定量した。さらに、デジタルマイクロスコープ(キーエンス社)を使用して、コーティング層の性状(ひび割れの状態)を観察し、上記評価基準にしたがい、評価した。
Claims (9)
- 基板と、基板上に配置されたマイクロニードルと、マイクロニードル上に形成されたコーティング層と、を備えるマイクロニードルデバイスであって、
コーティング層は、生理活性物質、アルギニン及びグリセリンを含有する、マイクロニードルデバイス。 - コーティング層において、
アルギニンの質量が、生理活性物質の質量に対して0.06〜0.85倍であり、
グリセリンの質量が、コーティング層全体の質量に対して40%以下である、請求項1に記載のマイクロニードルデバイス。 - コーティング層は、クエン酸、リン酸、ホウ酸、酒石酸及び乳酸からなる群から選択される酸をさらに含有する、請求項1又は2に記載のマイクロニードルデバイス。
- 基板及びマイクロニードルを有するマイクロニードルアレイを準備する工程と、
生理活性物質、アルギニン及びグリセリンを混合してコーティング組成物を得る工程と、
マイクロニードルにコーティング組成物を塗布する工程と、
コーティング組成物を乾燥させてマイクロニードル上にコーティング層を形成する工程と、
を備える、マイクロニードルデバイスの製造方法。 - コーティング組成物は、クエン酸、リン酸、ホウ酸、酒石酸及び乳酸からなる群から選択される酸をさらに含有する、請求項4に記載の方法。
- コーティング層において、
アルギニンの質量が、生理活性物質の質量に対して0.06〜0.85倍となり、かつグリセリンの質量が、コーティング層全体の質量に対して40%以下となるまで乾燥を行う、請求項4又は5に記載の方法。 - 請求項4〜6のいずれか一項に記載の方法により製造されるマイクロニードルデバイス。
- 生理活性物質、アルギニン及びグリセリンを含有する、マイクロニードル用コーティング剤。
- クエン酸、リン酸、ホウ酸、酒石酸及び乳酸からなる群から選択される酸をさらに含有する、請求項8に記載のコーティング剤。
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WO2016039418A1 (ja) | 2016-03-17 |
TW201611859A (en) | 2016-04-01 |
EP3192556A1 (en) | 2017-07-19 |
JP6712224B2 (ja) | 2020-06-17 |
US10537723B2 (en) | 2020-01-21 |
KR102169536B1 (ko) | 2020-10-23 |
US20200061359A1 (en) | 2020-02-27 |
EP3192556A4 (en) | 2018-05-09 |
CN106687172A (zh) | 2017-05-17 |
CN106687172B (zh) | 2020-06-23 |
TWI702061B (zh) | 2020-08-21 |
US20170266427A1 (en) | 2017-09-21 |
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